Clearance for an electronic chart recorder (e-chart system) for the hull 2 and hull 3 lyophilizer (freeze dryer). The e-chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or information transfer capabilities.
| Device | COLLASTAT INSTAT ABSORABLE COLLAGEN HOMESTATIC AGENTS |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2016-11-07 |
| Decision Date | 2016-12-07 |
| PMA | P810006 |
| Supplement | S074 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P810006 | | Original Filing |
| S101 |
2022-11-21 |
30-day Notice |
| S100 |
2022-06-06 |
30-day Notice |
| S099 |
2022-04-20 |
30-day Notice |
| S098 |
2022-04-04 |
30-day Notice |
| S097 |
2021-07-16 |
30-day Notice |
| S096 | | |
| S095 | | |
| S094 |
2021-01-27 |
30-day Notice |
| S093 |
2021-01-07 |
30-day Notice |
| S092 |
2020-12-23 |
30-day Notice |
| S091 |
2020-10-19 |
30-day Notice |
| S090 |
2020-08-05 |
30-day Notice |
| S089 |
2019-05-28 |
30-day Notice |
| S088 |
2019-04-08 |
30-day Notice |
| S087 |
2019-04-08 |
30-day Notice |
| S086 |
2019-03-27 |
30-day Notice |
| S085 |
2019-03-21 |
30-day Notice |
| S084 |
2019-02-13 |
30-day Notice |
| S083 | | |
| S082 |
2018-04-20 |
30-day Notice |
| S081 |
2018-03-26 |
30-day Notice |
| S080 |
2018-01-11 |
30-day Notice |
| S079 |
2017-12-22 |
135 Review Track For 30-day Notice |
| S078 |
2017-09-29 |
30-day Notice |
| S077 |
2017-08-02 |
30-day Notice |
| S076 |
2017-03-31 |
30-day Notice |
| S075 |
2017-01-30 |
30-day Notice |
| S074 |
2016-11-07 |
30-day Notice |
| S073 |
2016-08-19 |
30-day Notice |
| S072 |
2016-05-25 |
30-day Notice |
| S071 |
2016-02-26 |
135 Review Track For 30-day Notice |
| S070 |
2016-02-19 |
30-day Notice |
| S069 | | |
| S068 |
2015-08-24 |
135 Review Track For 30-day Notice |
| S067 | | |
| S066 | | |
| S065 |
2015-03-30 |
30-day Notice |
| S064 |
2015-03-23 |
30-day Notice |
| S063 |
2015-03-20 |
30-day Notice |
| S062 |
2015-03-18 |
30-day Notice |
| S061 |
2015-03-02 |
30-day Notice |
| S060 |
2015-02-24 |
30-day Notice |
| S059 |
2015-02-18 |
30-day Notice |
| S058 |
2014-11-20 |
30-day Notice |
| S057 |
2014-10-21 |
30-day Notice |
| S056 |
2014-09-22 |
30-day Notice |
| S055 |
2014-09-15 |
30-day Notice |
| S054 | | |
| S053 |
2014-04-11 |
135 Review Track For 30-day Notice |
| S052 |
2014-04-10 |
30-day Notice |
| S051 |
2014-04-10 |
30-day Notice |
| S050 |
2013-12-20 |
30-day Notice |
| S049 |
2013-11-06 |
135 Review Track For 30-day Notice |
| S048 |
2013-11-01 |
135 Review Track For 30-day Notice |
| S047 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S046 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S045 |
2013-08-01 |
30-day Notice |
| S044 |
2013-07-31 |
30-day Notice |
| S043 |
2013-05-28 |
30-day Notice |
| S042 |
2013-05-23 |
30-day Notice |
| S041 |
2013-05-22 |
30-day Notice |
| S040 |
2013-05-21 |
30-day Notice |
| S039 |
2013-05-16 |
30-day Notice |
| S038 |
2013-05-15 |
30-day Notice |
| S037 |
2013-05-14 |
30-day Notice |
| S036 |
2013-05-01 |
135 Review Track For 30-day Notice |
| S035 |
2012-08-31 |
30-day Notice |
| S034 |
2012-08-23 |
30-day Notice |
| S033 |
2010-05-24 |
30-day Notice |
| S032 |
2009-02-02 |
Normal 180 Day Track No User Fee |
| S031 |
2008-03-17 |
30-day Notice |
| S030 |
2007-10-01 |
30-day Notice |
| S029 |
2007-09-05 |
30-day Notice |
| S028 |
2007-06-22 |
30-day Notice |
| S027 |
2007-01-12 |
30-day Notice |
| S026 |
2006-12-12 |
30-day Notice |
| S025 |
2006-11-28 |
30-day Notice |
| S024 |
2006-10-11 |
30-day Notice |
| S023 |
2005-12-06 |
30-day Notice |
| S022 |
2005-09-30 |
Normal 180 Day Track No User Fee |
| S021 |
2003-04-11 |
30-day Notice |
| S020 |
2001-06-08 |
Real-time Process |
| S019 |
1995-07-26 |
Normal 180 Day Track |
| S018 |
1993-06-18 |
Normal 180 Day Track |
| S017 |
1993-03-11 |
Normal 180 Day Track |
| S016 |
1992-06-24 |
Normal 180 Day Track |
| S015 | | |
| S014 | | |
| S013 |
1991-05-20 |
Normal 180 Day Track |
| S012 |
1989-04-24 |
Normal 180 Day Track |
| S011 |
1988-12-29 |
Normal 180 Day Track |
| S010 | | |
| S009 |
1988-10-17 |
Normal 180 Day Track |
| S008 |
1985-09-06 |
|
| S007 |
1985-03-05 |
|
| S006 |
1984-05-22 |
|
| S005 |
1983-08-19 |
|
| S004 | | |
| S003 |
1983-05-09 |
|
| S002 |
1982-02-11 |
|
| S001 |
1982-01-27 |
|
NIH GUDID Devices